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Deanxit and Rivotril in Tinnitus Patients

This study has been completed.
Information provided by:
University Hospital, Antwerp Identifier:
First received: January 30, 2009
Last updated: August 10, 2009
Last verified: August 2009
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Condition Intervention Phase
Tinnitus Drug: Deanxit Drug: Lactose placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Resource links provided by NLM:

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 3 weeks, 6 weeks ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactose placebo
Drug: Lactose placebo
Lactose used as placebo
Experimental: Deanxit Drug: Deanxit
Deanxit 1x/day


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pure tone, narrow band noise or polyphonic tinnitus
  • unilateral or bilateral tinnitus
  • VAS ≥ 4

    • cochleair origin tinnitus
    • tinnitus present 3 months or more
    • age 18y or more
    • intake Rivotril 1mg/d
    • patient 'able to cooperate'
    • patient able to fill in TQ en VAS
    • No pontine angle pathology on MRI

Exclusion Criteria:

  • pulsatile tinnitus
  • pregnancy or breast feeding
  • contra-indications Deanxit
  • recovery myocard infarct
  • conduction disorder His
  • untreated glaucoma
  • MAO inhibitors: 15d stop
  • otosclerosis
  • middle ear pathologies
  • Ménière
  • somatic tinnitus
  Contacts and Locations
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Please refer to this study by its identifier: NCT00841230

Antwerp University Hospital
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Principal Investigator: Olivier Meeus, MD University Hospital, Antwerp
  More Information

Responsible Party: Prof Dr P H Van de Heyning, Antwerp University Hospital Identifier: NCT00841230     History of Changes
Other Study ID Numbers: 8/46/260
Study First Received: January 30, 2009
Last Updated: August 10, 2009

Keywords provided by University Hospital, Antwerp:

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 18, 2017